HK1261659B - A non-invasive sensing system - Google Patents

Description

Non-invasive sensing systems

Technical Field

The present invention relates to a non-invasive sensing system.

The present invention may be suitable for use in non-invasively detecting the presence of a substance and/or measuring the concentration of the substance within a subject.

More specifically, the present invention is particularly suitable for non-invasively detecting the presence of substances (e.g., metabolites, lactate, urate, blood sugar (glucose), water, alcohol, and drugs) in the blood of an organism and/or measuring the concentration of the substances. Therefore, for convenience only, the present invention will be described primarily with respect to this application.

However, it is to be understood and appreciated that the present invention may have other applications and/or uses as well.

Therefore, the prior art and possible applications of the present invention as discussed below are given by way of example only.

Background Art

Diabetes mellitus, more commonly known as diabetes, is a chronic metabolic disease characterized by high blood sugar (glucose) levels over an extended period of time. It can also be described as a condition in which a person's blood sugar levels cannot be properly regulated by the body alone. Diabetes is an incurable condition (except in very specific circumstances).

There are three main types of diabetes, namely, type 1 diabetes, type 2 diabetes, and gestational diabetes.

Type 1 diabetes results from the failure of the pancreas to produce enough insulin.

Type 2 diabetes is caused primarily by a person's cells failing to respond properly to insulin (primarily, but not exclusively, due to a person having excess weight and/or a poor diet and/or not exercising enough).

Gestational diabetes occurs in pregnant women who have no previous history of diabetes.

Generally speaking, if a person takes a fasting blood test and records a blood sugar level below 5.5mmol/l, they do not have diabetes. If a level between 5.5mmol/l and 6.9mmol/l is recorded, they can be said to have impaired fasting glucose (a form of prediabetes), which increases their risk of developing type 2 diabetes. Levels above 6.9mmol/l usually mean that a person has diabetes.

Furthermore, if a person were to have their blood sugar tested at any time (rather than a fasting blood test), a blood sugar level above 11.1 mmol/l would generally mean that the person has diabetes.

As of 2015, an estimated 400 million people worldwide suffer from diabetes, with approximately 90% of cases being type 2. Consequently, the disease represents a significant health burden in virtually every country and causes a significant number of deaths each year.

The main treatments for diabetes include diet (to optimize blood sugar levels), insulin injections, and oral medications.

Control or management of blood sugar levels requires people with diabetes to regularly self-monitor or self-measure their blood sugar levels and (when deemed necessary) take the appropriate amount of insulin (or possibly consume the appropriate type of food/drinks to help restore balance if necessary).

Most people with type 2 diabetes measure their blood sugar levels at least once a day. However, people who use insulin to treat the disease (all type 1 diabetics and many type 2 diabetics) typically test their blood sugar levels more frequently (usually between two and ten times a day). More regular testing is primarily done to determine if or when a dose of insulin might be needed and/or to test the effectiveness of any previous insulin doses.

For existing diabetics, the most common method of measuring blood sugar levels is through a method known as a finger-prick test. This is an invasive procedure in which a person pricks their finger and applies the resulting droplet of blood to a glucometer, a medical device that can determine the concentration of blood sugar levels from the droplet of blood.

However, there are several disadvantages or drawbacks associated with the use of finger-stick testing and blood glucose meters.

First, many people are reluctant to endure the minor pain involved and/or the sight of blood.

Second, given the invasive nature of the procedure, there is always a risk of infection.

Third, finger-stick tests are not always accurate or consistent, as measurements can vary by as much as 15% from reality (or from more accurate laboratory tests).

Fourth, some people suffer from what is known as "fragile fingers," and this may hinder their ability (or desire) to measure their blood glucose levels as frequently as needed.

Finally, in the long term, the invasive nature of the finger stick test may cause damage to the finger tissue and/or result in a general feeling of ongoing discomfort in the finger.

Furthermore, a blood glucose meter only measures a person's blood glucose level each time the person draws blood by pricking their finger. That is, a finger-stick test does not enable a person to continuously monitor their blood glucose level over time. Consequently, a person cannot gain a more complete understanding of their blood glucose level or pattern over time (particularly while sleeping). Furthermore, any occurrences of hyperglycemia or hypoglycemia (and/or their possible causes) between discrete finger-stick tests cannot be noted or recorded.

As a result of the above-mentioned shortcomings or deficiencies, it would be advantageous if there were a non-invasive system available for measuring blood glucose levels, preferably with options for continuous (or more regular) monitoring.

There is currently a great deal of interest in first developing a cost-effective, accurate and practical system for the non-invasive (and preferably painless) measurement of blood glucose levels. To date, no such system is commercially available.

A fairly recent review of the many different non-invasive blood glucose monitoring technologies currently being studied and/or investigated can be found in Med Devices (Auckl) 2012;5:45-52.

US 2012/0130212, by Pluta et al., describes a system for noninvasively measuring a patient's blood metabolites by repeatedly measuring multiple electromagnetic impedance readings from both the patient's epidermis and dermis until the difference between the readings exceeds a specific threshold. An impedance value representing the difference is calculated using an equivalent circuit model and "personal adjustment factor data" representing the patient's physiological characteristics. The patient's blood metabolite level is then determined from the impedance value and a "blood metabolite level algorithm."

However, a drawback or disadvantage associated with Xylan is that the "personal adjustment factor data" and "blood metabolite levels" are specific to a particular patient profile or a group of patients with similar profiles. For example, one such group profile might be: "Caucasian female, 45 to 50 years old, weighing 120 to 130 pounds, with 15% to 18% body fat." When a patient falls into this profile, the blood glucose level can be determined using an impedance value representing the difference between the actual readings (epidermis and dermis) and a glucose algorithm customized for this patient profile. Xylan also describes a preferred embodiment by which a glucose algorithm is customized for each patient and for each patient. Therefore, because the system in Xylan requires that the patient first undergo a pre-test for fat content and be asked about their age and weight before the system can be used to determine a specific blood glucose reading for each patient, the system is somewhat impractical.

Furthermore, because Xtra allows for ranges to exist in the pre-test (e.g., 15% to 18% body fat or 45 to 50 years of age), the final determination of blood glucose levels will not always be accurate for each patient within these ranges. For example, a 45-year-old woman weighing 120 pounds and having 15% body fat will receive the same glucose algorithm as a 50-year-old woman weighing 130 pounds and having 18% body fat. This is clearly unsatisfactory, given the importance of accurate blood glucose readings.

US 2013/0225960 Porch describes a blood glucose monitor for non-invasive in vivo characterization of blood glucose levels in a living subject. The monitor includes a microwave resonator (actually a resonant cavity) having a resonant response to input microwaves and designed so that the response is perturbed by a living subject in the vicinity of or in contact with the resonator. The monitor also includes a detection device for detecting changes in the resonant response, from which the blood glucose level or a characteristic representative of the blood glucose level can be determined.

One possible drawback associated with Porch is that the microwave resonator must be built to pick out the frequency relevant to the target and therefore a differential resonator for each chemical targeted will likely be required.

US 8882670 Hancock describes an apparatus for (minimally) non-invasive measurement of a component contained within a biological tissue structure (one example being blood glucose levels). The Hancock comprises a microwave energy source; a first antenna coupled to the microwave energy source for transmitting microwaves into the tissue structure; and a second antenna configured to receive the transmitted microwaves after they have passed through the tissue structure. The Hancock also comprises a signal processor for determining a resonant frequency of the received microwaves; and a data processor configured to provide an output of the concentration of the component within the tissue structure based on the determined resonant frequency.

The Hancock method shares a similar disadvantage to the X-ray diffraction analysis of the X-ray diffraction analysis of the individual in that it requires individual pre-testing. Specifically, the thickness of the tissue structure must be known before individual measurements can be performed. Furthermore, because the thickness of biological tissue structures (and the composition of tissue structures, such as the thickness of skin, muscle, and fat layers) vary between individuals, the resonant frequency of any given component concentration in the tissue structure will vary from person to person.

Another disadvantage associated with the Hancock is that the microwaves must pass through a significant thickness of tissue (e.g., through an entire human arm or wrist) before they are received by the second antenna. Furthermore, the microwaves must pass through several layers of different types of tissue (e.g., skin, muscle, and fat). Because each tissue layer causes its own unique interaction with the microwaves (e.g., with respect to attenuation and phase), the device must deconvolute these interactions. This is impossible without knowing the thickness of each tissue layer (and therefore, the distance the microwaves must travel through each tissue layer).

EP 1620002 Esenaliev describes a non-invasive system for determining blood glucose levels in a patient, comprising an optical probe having a tip that is positioned above a vein beneath the patient's tongue. The probe tip includes an excitation port through which an input signal generated by a signal generator subsystem impinges on a tissue surface above the vein; and a response port through which a response signal is received by a detector and forwarded to an analyzer, which then converts the response signal into a concentration of a blood component and/or a value of a blood parameter. Esenaliev preferably requires a static magnetic or electric field.

US 2014/0213870 Hsu et al. describe a non-invasive blood glucose monitoring sensor for measuring blood glucose levels in a human body by placing the non-invasive blood glucose sensor near the human body. The sensor includes a substrate; a first metal layer formed on one surface of the substrate and including an internal microstrip antenna; and a second metal layer formed on an opposite surface of the substrate. The sensor also includes a blood glucose sensing unit electrically connected to the first and second metal layers and capable of providing an RF signal, wherein the blood glucose sensing unit outputs the RF signal to the first metal layer. Therefore, resonance is generated between the first metal layer, which carries the RF signal, and the blood glucose in the human body. The blood glucose level is calculated and displayed by the blood glucose sensing unit. An overlapping region and a non-overlapping region are provided between the first and second metal layers relative to the substrate to improve the bandwidth of the microstrip antenna and the sensitivity of the blood glucose sensing unit.

US 9198607 Fischer describes an armband that can be fitted to a person's arm. The armband includes a detection device for detecting a blood parameter of blood in a blood vessel in the arm, and a setting device for setting a predetermined contact pressure of the armband on the arm. The detection device includes a transmitter configured to transmit a wave signal into the person's arm, and a receiver configured to receive the signal after the signal has passed through the blood vessel. The setting device is configured in such a way that the setting device can set a predetermined or prescribed contact pressure at least during the detection of the blood parameter by the detection device.

Fischer has a similar disadvantage to Hancock in that the transmitted wave signal must pass through a significant thickness of tissue (e.g., through an entire human arm) before being received by the receiver. Fischer also requires applying pressure to the arm via an armband, and this can be an uncomfortable experience for some people.

US 2010/0324398 Tzyy-Ping is a difficult read but appears to describe a non-invasive blood glucose monitor that uses "RF impedance data" to determine blood glucose levels.

Cooke, S. J., S. G. Hinch et al. (2006). "Mechanistic basis of individualmortality in pacific salmon during spawning migrations." Ecology 87(6):1575-1586.

The above paper describes the use of a DistellFatometer that uses a microwave microstrip sensor to measure water content, and then uses calibration (for various fish) to estimate the fat content of the fish. Therefore, fat = factor x water.

However, the results as described appear rather unreliable. Furthermore, they only measure one component (water), which has the greatest effect, and the measurement occurs in the flesh of the fish. By inference, they also claim to be unable to measure a second (and only slightly more subtle) component. The system is handheld and manually operated.

Purpose

It is an object of the present invention to provide a non-invasive sensing system which goes some way towards addressing the aforementioned problems or difficulties or at least provides the public with a useful choice.

definition

Throughout this specification, unless the context requires otherwise, the word "comprise" and variations will be understood to imply the inclusion of stated integers or steps or groups of integers or steps but not the exclusion of any other integers or steps or groups of integers or steps.

Summary of the Invention

According to one aspect of the present invention, there is provided a non-invasive sensing system for measuring the concentration of a substance in an object, the system comprising:

a supporting device, the supporting device is adapted to be placed close to or against the surface of the object;

b. a first transmitting antenna mounted on or within a supporting device for transmitting an electromagnetic radiation signal to an object;

c. A second receiving antenna, which is mounted on or within the supporting device and is adjacent to the first transmitting antenna, and is used to receive a portion of the electromagnetic radiation signal that has been reflected back to the same surface of the object covered by the supporting device because the transmitted electromagnetic radiation signal has interacted with the material within the object to be measured.

According to another aspect of the present invention, there is provided a non-invasive sensing system for measuring the concentration of a substance within an object, substantially as described above, wherein the system further comprises an analyzer in electrical communication with the first transmitting antenna and the second receiving antenna, the analyzer being adapted to decompose the reflected signal received by the second receiving antenna into a spectrum or spectral file.

According to another aspect of the invention there is provided a non-invasive sensing system for measuring the concentration of a substance within a subject, substantially as described above, wherein the system further comprises a data processor adapted to receive a spectrum or spectrum file from the analyser and convert the readings into a measurement of the concentration of the substance within the subject.

According to another aspect of the present invention there is provided a non-invasive sensing system for measuring the concentration of a substance in a subject, substantially as described above, wherein the longitudinal axis of the first transmitting antenna is substantially orthogonal to the longitudinal axis of the second receiving antenna.

According to another aspect of the invention there is provided a non-invasive sensing system for measuring the concentration of a substance in an object, substantially as described above, wherein the polarity (or polarity axis) of the first transmitting antenna is substantially orthogonal to the polarity (or polarity axis) of the second receiving antenna.

According to another aspect of the invention there is provided a non-invasive sensing system for measuring the concentration of a substance in a subject, substantially as described above, wherein the central longitudinal axis of the second receiving antenna passes substantially through the midpoint of the first transmitting antenna and vice versa.

According to another aspect of the invention there is provided a non-invasive sensing system for measuring the concentration of a substance in a subject, substantially as described above, wherein the centre of the polarisation axis of the second receiving antenna may pass substantially through the midpoint of the first transmitting antenna, and vice versa.

According to another aspect of the invention there is provided a non-invasive sensing system for measuring the concentration of a substance within an object, substantially as described above, wherein the support device comprises a first conductive track for electrically connecting an analyser to a first transmitting antenna and a second conductive track for electrically connecting the analyser to a second receiving antenna, wherein the first conductive track is substantially orthogonal to the second conductive track.

According to another aspect of the invention, there is provided a non-invasive sensing system for measuring the concentration of a substance within an object, substantially as described above, wherein the analyzer is a vector network analyzer (VNA) and the VNA uses S-parameters to decompose the received signal from the second receiving antenna into a spectrum or spectrum file.

According to another aspect of the present invention there is provided a non-invasive sensing system for measuring the concentration of a substance within a subject, substantially as described above, wherein, in use, the first transmitting antenna and the second receiving antenna are in direct contact with a surface of the subject.

According to another aspect of the present invention there is provided a non-invasive sensing system for measuring the concentration of a substance in a subject, substantially as described above, wherein the substance being measured is a blood component in the blood of a living being.

According to another aspect of the present invention there is provided a non-invasive sensing system for measuring the concentration of a substance in a subject, substantially as described above, wherein the transmitted electromagnetic radiation signal is transmitted continuously.

According to another aspect of the present invention there is provided a non-invasive sensing system for measuring the concentration of a substance in a subject, substantially as described above, wherein the transmitted electromagnetic radiation signal is transmitted in pulses or chirps.

According to another aspect of the present invention there is provided a non-invasive sensing system for measuring the concentration of a substance within a subject, substantially as described above, wherein the support means comprises a printed circuit board.

According to another aspect of the present invention there is provided a non-invasive sensing system for measuring the concentration of a substance in a subject, substantially as described above, wherein the system is capable of or adapted to operate automatically at predetermined times.

According to another aspect of the present invention there is provided a non-invasive sensing system for measuring the concentration of a substance in a subject, substantially as described above, wherein the system is capable of or adapted to operate automatically and continuously.

According to another aspect of the present invention there is provided a non-invasive sensing system for measuring the concentration of a substance in a subject, substantially as described above, wherein the system is capable of or adapted to be manually operated by a user of the system.

According to another aspect of the present invention there is provided a non-invasive sensing system for measuring the concentration of a substance in a subject, substantially as described above, wherein the system is capable of measuring the concentration of a plurality of substances at any one time.

It should be understood and appreciated that the system can also be used to merely detect the presence of a substance within a subject, rather than measuring the concentration of a substance within a subject.

Therefore and according to another aspect of the present invention, there is provided a non-invasive sensing system for detecting the presence of a substance within a subject, the system comprising:

a supporting device, the supporting device is adapted to be placed close to or against the surface of the object;

b) at least one first transmitting antenna, the first transmitting antenna being mounted on or within the supporting device and configured to transmit an electromagnetic radiation signal into the object;

c) at least one second receiving antenna, which is mounted on or in the supporting device and is adjacent to the first transmitting antenna, and is used to receive a portion of the electromagnetic radiation signal that is reflected back to the same surface of the object covered by the supporting device because the transmitted electromagnetic radiation signal has interacted with the material in the object to be inspected.

According to another aspect of the present invention there is provided a method for detecting the presence and/or measuring the concentration of a substance within a subject, the method comprising the steps of using a non-invasive sensing system substantially as described above.

For convenience only, the present invention will be described primarily with respect to measuring the concentration of a substance within a subject, rather than solely with respect to detecting a substance. However, it will be understood that if a system can measure the concentration of a substance within a subject, then it can also detect that substance within the subject. Thus, the present invention is applicable to or used in two embodiments of the present invention as described below.

The analyzer may include a signal generator adapted to facilitate generation of an electromagnetic radiation signal transmitted by a first transmitting antenna (hereinafter: "first antenna").

The reflected electromagnetic radiation signal received by the analyzer (directly or indirectly) from the second receiving antenna (hereinafter: "second antenna") can be analyzed by the analyzer (or decomposed into a spectrum or spectrum file) using techniques such as S parameters ( _S11 , _S12 , _S21 and/or _S22 ) and/or transmission line parameters (power loss, phase angle, RGLC) and/or dielectric parameters ( _∑r , _∑r ', _∑r ").

In one embodiment, the analyzer may be a VNA.

Other examples of suitable analyzers include a voltage standing wave ratio meter (VSWR) or a vector voltmeter.

The data processor may include one or more software programs and/or algorithms and/or formulas that transform a spectrum or spectrum file received from the analyzer into a measurement of the concentration of the substance within the object being measured.

Any suitable support means may be used depending on the intended use of the sensing system.

Preferably, the support device may be in the form of or include a housing and/or a substrate, on which (or within which) the first antenna and the second antenna (and any other electronic devices or components) may be mounted. Examples of suitable support devices (and/or housings/substrates) will be described throughout this specification.

According to another aspect of the present invention, there is provided a non-invasive sensing system for measuring the concentration of a substance within a subject, substantially as described above, wherein the system further comprises an electronic control module (ECM) for controlling the overall operation of the system and/or analyzer and/or data processor.

The ECM may be a stand-alone unit, or it may comprise part of another component of the system (eg, an analyzer or data processor).

In an alternative embodiment, a data analyzer may be included as part of the ECM.

In one embodiment, the electromagnetic radiation signal may include a signal in the microwave spectrum.

In another embodiment, the electromagnetic radiation signal may include a signal in the radio spectrum.

It is also contemplated that other types of electromagnetic signals may be used.

In one embodiment, the electromagnetic radiation signal may include signals from two or more spectra.

In one embodiment, the electromagnetic signal may be transmitted continuously.

In another embodiment, the electromagnetic signal may be sent in pulses or chirps.

In one embodiment, the power of the transmitted electromagnetic radiation signal may be less than 500 mW, and preferably less than 50 mW.

Any suitable type or shape of antenna may be used. Examples of suitable antennas may include SMD antennas, wire antennas, traveling wave antennas, reflector antennas, microstrip antennas, log-periodic antennas, and aperture antennas.

In one embodiment, the system may include at least one first transmitting antenna and/or at least one second receiving antenna.

For example, there may be two transmit antennas and three receive antennas; or four transmit antennas and four receive antennas; or one transmit antenna and two receive antennas.

In another embodiment, multiple first antennas can be grouped together into essentially one first antenna unit. Similarly, multiple second antennas can also be grouped together into essentially one second antenna unit. Having multiple transmit and receive antennas throughout the first and second antenna units can help ensure that there is always at least one transmit antenna and at least one receive antenna above the substance being measured within the subject (e.g., above a person's artery/vein if blood components are the substance being measured).

Therefore, the term "first antenna" as used herein should be understood to also include reference to at least one first transmitting antenna, and/or a first antenna element, substantially as described above.

Furthermore, the term "second antenna" as used herein is to be understood as also including reference to at least one second receiving antenna, and/or a second antenna element, substantially as described above.

In one embodiment, the first antenna and the second antenna may be positioned proximate to each other on the support means.

In such an embodiment, it will be appreciated that the reflected electromagnetic radiation signal (received by the second antenna) is received in substantially the same location and on the same side of the object surface as the transmitted radiation signal when originally transmitted into the object by the first antenna.

The distance between the first antenna and the second antenna may be, for example, between 0.01 mm and 10 cm, but is preferably between 0.5 mm and 10 mm.

In one embodiment, the first antenna and the second antenna may lie in substantially the same plane relative to each other.

In alternative embodiments, the first antenna and the second antenna may be located in or on different planes.

In one embodiment, the first antenna and the second antenna may be substantially parallel with respect to each other.

In another embodiment, the first antenna and the second antenna may be angled relative to each other.

In such an embodiment, the first antenna and the second antenna may be angled relative to each other in substantially the same plane or in different planes (ie, different three-dimensional planes or configurations).

Preferably, the first and/or second antenna may be substantially rectangular in shape.

In a preferred embodiment, the longitudinal axis of the first antenna may be substantially orthogonal to the longitudinal axis of the second antenna.

In such an embodiment, the central longitudinal axis of the second antenna may preferably pass through the midpoint (meaning the center or the central area) of the first transmitting antenna, and vice versa.

It will be understood and appreciated that if the first and/or second antennas do not have a clearly defined longitudinal axis (e.g., square, circular, or hexagonal antennas), the structure can be such that the polarity (or polarity axis) of the first transmitting antenna can be substantially orthogonal to the polarity (or polarity axis) of the second receiving antenna.

In such an embodiment, the center of the polarization axis (or central axis) of the second receiving antenna may substantially pass through the midpoint (meaning the center or central area) of the first transmitting antenna, and vice versa.

In one embodiment, the first antenna and the second antenna may be embedded in and surrounded by the support device.

In another embodiment, the first and second antennas may be located on a surface of the support means and/or protrude from the support means, whereby, in use, the first and second antennas may be in direct contact with a surface of an object.

In this embodiment, but when used alternatively, one side of the support device may be in direct contact with the surface of the object, with the first and second antennas being located on or protruding from opposite sides of the support device.

In another embodiment, and in use, the support means and/or the first and second antennas may be adapted to be held just above the surface of the object.

In one embodiment, electromagnetic radiation signals transmitted into the subject and electromagnetic signals received back from the subject may describe or follow a transflective structure or pattern.

For convenience only and throughout this specification, the term "reflected" should be understood and construed to include both reflected and transflected electromagnetic radiation signals.

It will be appreciated that the reflected electromagnetic radiation signals received by the second antenna have not completely passed through the object, but rather they have only slightly penetrated into and out of the object, with the entry points (at which points the signals are sent) and exit points (at which points the signals are received) being essentially in the same part of (the surface of) the object and on the same side.

However, it should be understood and appreciated that only a portion of the electromagnetic radiation signal transmitted by the first antenna into the object will be reflected back toward the second receiving antenna. That is, a portion of the electromagnetic radiation signal transmitted by the first antenna into the object will simply pass through the object and/or be absorbed by the object.

In one embodiment, the support means may comprise a printed circuit board (PCB).

In one embodiment, the supporting means may comprise or be in the form of an adhesive patch that may be (temporarily) attached or adhered to the object.

In one embodiment, the substance being measured can be a blood component in the blood of a living body. For example, the system can be used to measure the concentration of glucose or lactate in human blood.

In such an embodiment, the support device may be adapted or capable of being worn by a person.

In such an embodiment and for example, the support device may be in the form of a belt that may be worn around a person's waist, arms, legs, neck, ankles, or wrists.

In another embodiment, the system and/or support device may be in the form of or contained within a smartphone.

In yet another embodiment, the system and/or support device may be in the form of or incorporated into a watch (or medical device) adapted to be continuously worn by a person.

In one embodiment or use, the system and/or support device may simply be placed near or directly adjacent to the surface of an object in order to take a reading.

In alternative embodiments or use, the system and/or support device may be placed against a surface of an object in order to take a reading.

In one embodiment, the system may be capable of or adapted to operate automatically at predetermined times. For example, the system may be configured to automatically take a measurement every hour (24 hours a day).

In another embodiment, the system may be capable of or adapted to operate automatically and (almost) continuously. For example, the system may be configured to automatically take a measurement every second or every minute (24 hours a day).

In another embodiment, the system may be capable of or adapted to be operated manually by the user of the system and at any time they decide or deem it appropriate to use the system.

In such an embodiment, if the system and/or support device is attached to a subject (or worn by a person), the user may manually operate the system by, for example, pushing an "on" button associated with the system.

If the system and/or support device is not attached to an object (or worn by a person), the user can manually operate the system by bringing the support device close to the surface of the object (or placing it on the surface) (and optionally pushing an "on" button if the system is not otherwise configured to automatically take measurements).

In one embodiment, the system may be capable of measuring the concentrations of multiple species at any one time.

In one embodiment, the system may be capable of communicating with an alarm device.

In such an embodiment and for example, an audible alarm may be associated with the system, or the audible alarm may be associated with an electronic device (such as a smartphone) to which the system has sent an appropriate signal, in which case a text or email may additionally or alternatively be generated and sent.

In such an embodiment, a component of the system (e.g., the ECM or data processor) can send a signal to activate an alarm when a predetermined condition is met (or not met). For example, an alarm can be activated if impurities, microorganisms, or contaminants are detected in a milk (or milk powder) pipeline or if a person's blood sugar or lactate levels are dangerously low or high.

Preferably, the system may further comprise a power supply device for powering the operation of the system as a whole, such as powering the analyser and/or the data processor and/or the ECM and/or the first and second antennas and/or the alarm (if housed in the system).

In one embodiment, the power supply device may be a small battery contained within the system or system component. The battery may be disposable or rechargeable.

The system or any component thereof may further comprise suitable power supply means enabling the system or any component thereof to be powered by a mains power source (eg by an electrical plug or USB port/cable).

The system may include a communication device for transmitting any or all measurements or other data, or any work on the measurements or other data, to another location, such as a computing system or other electronic device.

The communication device may also be capable of receiving any kind of data.

The communication device may be a wireless communication device, for example a wireless transceiver housed within the ECM or the analyzer or the data processor.

Any suitable wireless technology known in the art may be used, including Wi-Fi (IEEE 802.11), LE other radio frequency, infrared (IR), GSM, CDMA, GPRS, 3G, 4G, W-CDMA, EDGE or DCDMA200, and the like.

Alternatively, any suitable wired connection or port may be used, including but not limited to a USB port or any other related or appropriate technology known in the art.

Computing devices or other electronic systems or devices (outside of the sensing system) include but are not limited to mobile phones, smart phones, iPhones, iPads, tablet computers, handheld computers, bands or other wearable technology devices, small portable devices, laptops, desktop computers, cloud computing systems, remote network computer systems (public networks, such as websites, or alternatively private networks) or to network services.

The system can be configured to activate the communication device as needed or desired or when needed or desired to transmit (and/or receive) measurements or any other data to/from a computing system or other electronic device (external to the system). For example, the transmission can be performed in real time, manually, continuously, or automatically at a predetermined set time.

In some embodiments, the system or any component thereof can be configured to receive any type of information or data from another location and/or computer system or electronic device outside the system using a communication device. For example, a software update for an antenna, ECM, analyzer, or data processor can be sent in this way.

In one embodiment, the system may be paired with a smartphone loaded with a specific and dedicated software application that allows the smartphone to receive, access, process, display, transmit, and/or present measurements or data collected by the system.

In such an embodiment and for example, the analyzer may send a spectrum or spectrum file to a smartphone application (via a communication device), which may then act as a data processor to transform the received data into an appropriate measurement result (of the concentration of the substance being measured within the subject).

In another embodiment, the smartphone application may be configured to receive the reflected electromagnetic radiation signal from the second antenna (via the communication device) before sending the electromagnetic radiation signal to the remote analyzer and/or data processor.

The system or any component thereof may include a memory or data storage device for storing measurements or any other data.

Alternatively, the memory or data storage device may be housed within a computing system or other electronic device in communication with the system.

The system may also include a user interface.

Alternatively, the user interface may comprise a portion of a computing system or other electronic device in communication with the system.

It is contemplated that the system may be used to detect and/or measure the concentration of any type of substance in any type of subject.

That is, the system may be suitable or capable of being used to non-invasively detect the presence and/or measure the concentration of any type of element, molecule, subject, biological tissue, microorganism, impurity, contaminant, chemical or other substance in any type of body, material, substance, material or other object (living or otherwise).

However, it is contemplated that the system may be particularly suitable for measuring the concentration of metabolites or any other substance in the blood of a living being, such as a human or animal. For example, the system may be used to measure the concentration of substances in human blood, such as lactate, urate, blood sugar (glucose), water, alcohol, drugs, etc.

Preferred embodiments

The description of the preferred forms of the invention provided herein with reference to the accompanying drawings is given by way of example only and is not to be considered in any way as limiting the scope or extent of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a diagram of one possible embodiment of the present invention;

FIG2 is a view of the embodiment of FIG1 showing transmitted and reflected electromagnetic radiation signals when the embodiment is placed against a skin surface;

3 is a diagram showing the field lines of the antenna of the present invention as illustrated in FIG1 and FIG2 when the embodiment is close to the skin surface;

FIG4 is a schematic diagram of a possible embodiment of the present invention;

FIG5 is a view of the embodiment of the present invention illustrated in FIG1 in use;

FIG6 is a diagram of an embodiment of the present invention incorporated into a mobile phone;

FIG7 is a view of an embodiment of the present invention in the form of a wearable watch or wristband;

FIG8 is a diagram showing different possible structures of the antenna of the present invention;

FIG9 is a spectral profile or graph resulting from the testing of Volunteer 1; and

FIG10 is an Excel table showing the conversion of spectral profile data into identifiable values for the blood glucose level of Volunteer 1 (compared to the equivalent prick test results).

DETAILED DESCRIPTION

1 to 5 , a non-invasive sensing system for measuring the concentration of blood glucose 23 (shown as dots in FIGS. 2 and 3 ) within a person's blood 14 is shown, generally indicated by arrow 1 .

The system 1 comprises a support device in the form of a PCB 22, generally indicated by arrow 34 ( FIG. 4 ), which is adapted to be placed close to ( FIG. 3 ) or against ( FIG. 2 ) a person's skin surface 4 , preferably in the region of the inner surface of a person's wrist 8 ( FIG. 5 ).

The PCB 22 is composed of a non-water absorbing dielectric material and may ideally be between 0.1 mm and 5 mm thick, with a preferred thickness of 0.7 mm.

In an alternative embodiment and for use in short-term use applications, PCB 22 may instead be composed of a water-absorbing dielectric material.

The system 1 comprises a first transmitting antenna 2 mounted on a PCB 22 for transmitting an electromagnetic radiation signal 3 into (and through) a skin surface 4 of a person.

The system also includes a second receiving antenna 5, which is mounted on the PCB 22 and is directly adjacent to the first antenna 2, and is used to receive the electromagnetic radiation signal that is reflected back to or toward the same part or area of the skin surface 4 covered by the PCB because the transmitted electromagnetic radiation signal 3 has interacted with the glucose molecules in the human artery/vein 13.

The first antenna 2 and the second antenna 5 are commercially available SMD antennas.

The system 1 further comprises an analyser in the form of a two-port VNA 15 which is in electrical communication with the first antenna 2 and the second antenna 5 via coaxial cables 24a, 24b, ports 25a, 25b and conductive tracks 26a, 26b.

In practice, and as will be known to those skilled in the art, there will be two conducting tracks to each antenna 2, 5, however, for simplicity we have only drawn a single track 25a, 25b.

Among other things (described later), the VNA is adapted to decompose (using S-parameters) the reflected or returned signal 6 received by the second antenna 5 into a spectrum or spectrum file.

VNAs with more than two ports may also be used.

The system further comprises a data processor 21 adapted to receive the spectrum or spectrum file from the VNA 15 and convert the reading into a measurement of the concentration of blood glucose 23 within the blood 14 of the artery/vein 13 of the person being examined.

The first antenna 2 and the receiving antenna 5 are directly adjacent to each other and are substantially in the same plane.

With respect to FIG. 1 , it can be seen that the longitudinal axis 27 of the first antenna 2 is substantially orthogonal to the longitudinal axis 28 of the second antenna 5. Thus, the polarization of the first antenna is substantially orthogonal to the polarity of the second antenna. This configuration is preferred because it minimizes coupling or interference between the first antenna 2 and the second antenna 5. Furthermore, positioning the second (receiving) antenna 5 substantially at right angles to the first (transmitting) antenna 2 means that the second antenna 5 is better positioned to select or receive the reflected signal 6 due to the change in phase and/or rotation and/or attenuation that the transmitted wave 3 undergoes as a result of being reflected (at point 39 in FIG. 2 ).

Furthermore, it can be seen that the (central) longitudinal axis 28 of the second antenna 5 passes substantially through the midpoint 29 of the first antenna 2. This is the preferred configuration of the first antenna 2 relative to the second antenna 5.

The ports 24a, 24b of the VNA can be interchanged, whereby the second antenna 5 becomes the transmitting antenna and the first antenna 2 becomes the receiving antenna. In this embodiment, it will be appreciated that, despite this, the (central) longitudinal axis 28 of the second antenna 5 (now the transmitting antenna) still substantially passes through the midpoint 29 of the longitudinal axis 27 of the first antenna 2 (now the receiving antenna).

With reference to FIG. 1 (in which the various components and distances are not drawn to scale), distance "a" is approximately 5 mm, distance "b" is approximately 6 mm, and distance "c" is approximately 2 mm.

The first conductive track 26a for electrically connecting the VNA 15 to the first antenna 2 is substantially orthogonal to the second conductive track 26b for electrically connecting the VNA 15 to the second antenna 5. This structure is preferred because it minimizes coupling or interference between the first conductive track 26a and the second conductive track 26b.

Placing the antennas 2, 5 in a substantially orthogonal relationship in combination with the substantially orthogonal relationship of the first and second conductive tracks 26a and 26b substantially minimizes (at least) or completely eliminates (at most) coupling or interference between the first and second conductive tracks 26a and 26b and/or coupling or interference between the first and second antennas 2, 5.

3 and 4 , it can be seen that the first antenna 2 and the second antenna 5 slightly protrude from the surface of the PCB 22 .

In FIG3 , PCB 22 is held above skin surface 4 along with first antenna 2 and second antenna 5. Near-field lines 30 are field lines generated by the electromagnetic signal transmitted by first antenna 2, and near-field lines 31 are field lines received by second antenna 5 after the electromagnetic signal associated with field lines 30 has been reflected off blood glucose molecules 23 and/or bottom 32 of artery 13.

In Figure 2, the PCB 22 is placed in close proximity to the skin surface 4, with the first antenna 2 and the second antenna 5 being in direct contact with the skin surface 4. This is the preferred configuration when using the sensing system 1 for this purpose.

In FIG. 2 , it can be appreciated that the reflected signal 6 is received by the second antenna 5 in substantially the same location in the skin 4 and on the same side of the skin surface 4 (of the wrist 8 ) as the transmitted radiated signal 3 was originally transmitted by the first antenna 2 .

The first transmitting antenna 2 transmits a fast pulsed electromagnetic radiation signal 3 in the form of a broadband (wideband) low power signal.

More specifically, the first antenna 2 transmits an electromagnetic radiation signal 3 in the form of a continuous wave with a frequency between 4 MHz and 4 GHz and a power signal of less than 2 mW.

The first antenna 2 and the second antenna 5 are both approximately 0.18 cm ² , so this results in a power density of approximately 11 mW/cm ² .

The transmitted signal 3 typically penetrates up to approximately 10 mm within a person's skin 4 and/or underlying tissue before being absorbed by the skin 4 (or underlying tissue).

With respect to FIG. 2 , it can be seen that a portion 33 of the transmitted signal 3 simply passes to the right through the artery 13 where it is absorbed by the underlying tissue (ie, the signal portion 33 is not reflected back to the second antenna 5 ).

In most (but not all) cases, the points 39 at which the transmitted signals 3 are reflected back as reflected signals 6 will typically be between 1 mm and 5 mm below the skin surface 4 .

At point 39 where the transmitted signals 3 are reflected back as reflected signals, they are rotated in phase before being received by the second antenna 5. Furthermore, the reflected signals 6 also experience phase changes and attenuation changes due to having interacted with the glucose molecules 23. These changes in dielectric effects are measured by the VNA 15 to produce a spectrum file, which is ultimately converted into a blood glucose reading by the data processor 21.

Compared to when the first and second antennas 2, 5 (and/or PCB 22) are held directly above the skin 4 ( FIG. 3 ), the coupling between the first antenna 2 and the second antenna 5 is increased by 100x when the antennas 2, 5 are in contact with the skin 4 ( FIG. 2 ). This results in absorption or resonant lines or curves in the scans _S11 and _S22 performed by the VNA 15. _S12 and _S21 convey the coupling level. Scans _S11 , _S21 , _S12 , and _S22 are recorded and/or analyzed by the VNA and converted into spectra or spectra files, which are then sent to the data processor 21, where they are converted into recognizable blood glucose concentrations (in mm/l).

Now referring to known technology, when an electromagnetic radiation signal travels between two antennas (a "transmitter" and a "receiver"), a stable electromagnetic field is created. In addition, the characteristics of these fields and field lines can be measured. It should be noted that the field only needs to be stable for the time period during which the measurement is made, so if very high-speed signal capture circuitry is used, high-speed pulsed fields and/or "time-of-flight" linear frequency chirps of only a few wavelengths' duration can be considered stable. There are devices that can generate pulses/linear frequency chirps (short electromagnetic pulses) at very specific frequencies. There are also devices that can generate a series of linear frequency chirps at different frequencies very quickly, create a stable field, capture the signal and measure the parameters of the field. The data output of such a device can be called a spectrum. A spectrum of hundreds of discrete data points (frequency steps) can be captured in a few milliseconds.

The electromagnetic field can be characterized using several techniques, including but not limited to: "S-parameters (S ₁₁ , S ₁₂ , S ₂₁ , and S ₂₂ )", transmission line parameters (power loss, phase angle, RGLC), and dielectric parameters (∑ _r , ∑ _r ', ∑ _r ”)". This data can also be analyzed to discern the characteristics of the antenna, the wave itself, and the material with which the wave interacts.

Electromagnetic radiation signals interact with materials in several ways.

For example, electromagnetic radiation signals can be reflected (e.g., by mirrors and radar), diffracted, refracted (e.g., by optical prisms), have their velocity altered (causing a phase change along the wave path), be partially or completely absorbed, or be polarized. Furthermore, the extent of these effects typically varies with frequency and is specific to the interacting materials. Each of these interactions affects the electromagnetic radiation signal differently and can therefore be inferred from the wave properties. These interactions can be described as dielectric parameters and mathematically modeled using field parameters.

The received signal may be attenuated, but need not be. For example, in a preferred signal, the reflected wave is 180 degrees out of phase, but has not yet been attenuated. The prism refracts (light) into different wavelengths (or different frequencies in the case of microwaves), but again, without loss or attenuation.

Dielectric parameters are mathematical terms that describe the effect of a material (e.g., blood) on waves. In homogeneous and stable materials (like plastic and water), these values are very consistent. The terms will generally tell the model the phase change and attenuation of a wave per unit distance traveled in the material (medium). These terms can include (a) phase and attenuation at different frequencies, (b) real and imaginary vectors, and (c) _Er , _E'r , and _Er ". From these other parameters, one can determine parameters such as (d) RGLC (used in equations involving frequencies to obtain values for (a) and (b)) and (e) α and β, which describe the attenuation and phase loss per unit length in the material at any frequency. Transfer functions can be used to convert between some models and their associated parameters. For example, S parameters can be converted to _Er parameters using mathematical operations involving complex numbers.

Field parameters (or field shape parameters) describe the geometric shape of the field. Field parameters can determine what mathematical model to use (and the complexity and difficulty of the solution).

When an electromagnetic radiation signal passes through a biological fluid (e.g., blood, urine, saliva, juice, etc.), the signal can interact with the fluid in several ways:

Salt ions and polar molecules are driven by the electric and magnetic fields and migrate to regions of opposite charge. The ions absorb some of the wave's energy as they accelerate toward the poles or decelerate as they move in the opposite direction of the force. However, in electromagnetic fields, regions of charge constantly and rapidly change poles, causing the ions to constantly accelerate, decelerate, and change direction, absorbing energy proportional to the moment of inertia they must overcome. This effect is most pronounced at low frequencies and when the ions and molecules are large and/or highly charged.

• Water and polar molecules can also be driven into alignment with the field by rotating about their center of mass and absorb energy as they build (lose) inertia during acceleration (deceleration). This effect is most pronounced in the microwave region.

• Biological compounds (whether polar or non-polar) may also have bonds and structures that resonate, bend, or otherwise distort at specific frequencies or angles of incidence.

●All materials change the speed of waves, thus imparting a phase change.

This technique works best on polar molecules, but detection only needs to be based on the effects of molecular properties (e.g., absorption, attenuation, phase change, etc.). For example, benzene is a nonpolar molecule, but it behaves in a specific way in an electromagnetic field (due to its ring structure and electron distribution). Similarly, ice and water behave very differently (because ice molecules cannot rotate).

Referring again to the drawings and most particularly to FIG. 4 , the VNA 15 includes a signal processing unit 9 (SPU).

One function of the SPU 9 is to facilitate transmission of the electromagnetic radiation signal 3 by the first antenna 2. This is facilitated by the SPU 9 being in electrical communication with a signal generator 10 which in turn is in electrical communication with the first antenna 2.

Another function of the SPU 9 is to receive (or facilitate the reception of) the reflected radiation signal 6. To accomplish this, there is a signal receiver 11 that is in electrical communication with both the second antenna 5 and the SPU 9. The transmitted or reflected electromagnetic radiation signal 6 initially received by the second antenna 5 is then sent to the signal receiver 11, which in turn sends the signal to the SPU 9.

The received signal 6 is analyzed in the SPU 9 by initially digitizing the received signal 6 and then decomposing the digitized signal 6 into a spectrum or spectrum file.

Alternatively, examples of other possible ways of decomposing the signal 6 into spectra or spectral files include power loss and phase and time of flight.

The spectrum or spectrum file is then passed to a data processor 21 and converted into dielectric properties (such as phase angle, power loss; α and β values; ∑r, ∑r’ and ∑r”) and spectrally analyzed using chemometric methods for resolving components of interest (such as and for example, N-PLS, PCA, neural network analysis, radio signal processing methods (preferably), time-of-flight Fourier transform).

The data processor 21 also comprises appropriate algorithms which, when applied to the components of interest (of a spectrum or spectrum file), ultimately allow the blood glucose level of the person to be determined. A specific example of one of the calculations involved will be described later.

If we look at miniaturizing the system 1 , it is envisioned that the VNA circuitry could be built into the back of the antenna 2 , 5 .

Attenuation is the energy loss measured by comparing the energy (Po) of the transmitted radiated signal 3 to the energy (P) of the received radiated signal 6. Attenuation = P/Po (usually reported in dB).

Therefore, to “confine the field” we can reduce the energy of the transmitted radiated signal 3 (typically by inserting an attenuator in the circuit between the signal generator 10 and the first antenna 2) so that it cannot penetrate so far into the wrist 8 (the attenuation is proportional to the natural logarithm of the distance traveled, so once we know α we can calculate the required power exactly, or we can do it empirically by trying attenuators of different strengths until we achieve the desired effect).

Therefore, if we set the strength of the transmitted signal 3 so that the near-field lines pass only through the skin 4 and blood 14 (i.e., closest to the first antenna 2 and the second antenna 5), we will measure the strength of the signal received at the second antenna 5, and any radiated signal 33 that enters the tissue (behind the artery/vein 13) will be too weak and should be completely absorbed (or completely pass through the wrist 8). In practice, and preferably, we optimize the signal to give us enough signal strength to achieve a usable signal-to-noise ratio while minimizing the "noise" of the tissue. Since we have to pass through the skin 4, we can't do much about it, so we try to do this as "constantly" as possible.

If a person has a significant layer of fat tissue beneath their skin that the transmitted electromagnetic signal 3 must first pass through before interacting with the artery/vein 13, then we can increase the power level as needed. That is, increase the power signal to more than 2 mW (this was the example given previously) so that the transmitted electromagnetic signal 3 has enough power to pass through the significant layer of fat before interacting with the artery/vein 13 and then returning as the reflected electromagnetic signal 6.

The electromagnetic radiation signals 3 sent into the wrist 8 and the electromagnetic signals 6 received from the wrist 8 may describe or follow transmissive structures or patterns within the electromagnetic field that has been created.

The data processor 21 (or ECM 21) includes (or communicates with) wireless communication means in the form of a wireless transceiver 16 for transmitting (and/or receiving) any or all measurement or other data or any operations on the measurement and other data to a remote location or computing device.

In this case, the wireless transceiver 16 is adapted to send its transmissions to the examined person's smartphone 17. The smartphone 17 comprises a downloaded application specific to the system 1 for receiving and/or manipulating and/or displaying measurements or other received data or for any work with measurements or other data.

The smartphone 17 includes an alarm 18 (in this case, an audible alarm associated with the smartphone 17), to which the data processor 21 or ECM 12 is programmed to send an appropriate signal (via the transceiver 16) when predetermined conditions are met (e.g., the person's blood glucose level is dangerously low or high and/or an insulin injection is required).

It is also contemplated that a text or email may additionally or alternatively be generated for sending.

Furthermore, the data processor 21 or ECM 12 may also be adapted to wirelessly transmit (via the transceiver 16 ) the measurement results and/or any other data or alarm alerts to the person's healthcare professional 19 or the cloud computing system 20 .

In an alternative embodiment, the PIC chip, cellular chip, and/or alarm may be placed on the same circuit board in the VNA.

The data processor 21 or ECM 12 can be configured to cause the wireless transceiver 16 to send and/or receive measurements or other data to/from a person's smartphone 17 or a cloud computing system as needed or desired. The transmission can be in real time, manually, or at a predetermined set time.

In some embodiments, the system 1 or ECM 12 may be configured to receive data or information from a person's smartphone 17 (or cloud computing system 20). For example, software updates for the ECM 12 or data processor 21 or VNA 15 may be sent this way.

Preferably, the smartphone 17 may be configured to transmit measurements or other data obtained from the system 1 to a web service platform (not shown).

Preferably, the system may include memory (not shown) for storing measurements or other data or any work on the measurements or other data. Preferably, the memory may be stored in the ECM 12 , the data processor 15 and/or the smartphone 17 .

In some embodiments, volatile computer memory including RAM, DRAM, SRAM can be used. In this case, the system can continuously send measurement results or other data to the smart phone 17 or medical professional 19 or cloud computing system 20.

In other embodiments, non-volatile memory formats may be used, including ROM, EEPROM, flash memory, ferroelectric RAM (F-RAM), optical and magnetic computer memory storage devices.

The system 1 may also comprise a user interface, preferably as part of a smartphone application.

The user interface may also be used to access measurements or other data recorded or received/sent by the system 1 , and to change any settings of the system 1 (eg date/time, visual/audio alarm settings).

The user interface may also be used to access any measurements or other data received (or sent) by the system 1 or to control the uploading of measurements or other data.

In one embodiment, the system 1 may be capable of or adapted to operate automatically and/or continuously. For example, the system 1 may be configured to automatically take a measurement every hour (24 hours a day).

In another embodiment, the system 1 may be capable of or adapted to operate automatically and (almost) continuously. For example, the system 1 may be configured to automatically take a measurement every second or every minute (24 hours a day).

Alternatively and/or additionally, the system 1 may be capable of or adapted for manual operation. For example, a person may place the PCB 22 on the inside of their wrist 8 and manually take a reading, for example by engaging an "on" button associated with the system 1 (or smartphone application).

In the illustrated embodiment, the support device 34, VNA 15, data processor 21, and transceiver 16 (collectively referred to herein as the "component") can be housed within its own housing (not shown), which can be carried, for example, by a person. It follows that the person's smartphone 17 (and associated applications) can be adapted or capable of operating or communicating with the component. Thus, the component and application combine to operate or facilitate the operation of system 1.

FIG5 illustrates how the embodiment illustrated in FIG1 can be used in practice. As shown, a person wishing to obtain a blood glucose reading places PCB 22 against the inner surface of their wrist 8. However, it is contemplated that PCB 22 could be placed against any skin surface, such as the neck, legs, feet, or chest. However, the wrist is a preferred location given that it has at least one artery 13 close to the skin surface 4.

The PCB 22 is connected to the VNA 15 which in turn is connected to a data processor in the form of a laptop computer 37 .

Preferably, the PCB 22 should be placed on the wrist 8 wherein the longitudinal axis of the first antenna 2 or the longitudinal axis of the second antenna 5 is substantially aligned with the longitudinal axis 38 of the at least one artery 13, as this allows for higher accuracy in blood glucose readings (compared to when the PCB 22 is placed on the wrist 8 wherein the longitudinal axes 27, 28 of the antennas 2, 5 are both angled relative to the longitudinal axis 38 of the at least one artery 13).

6 , the first antenna 2 and the second antenna 5 are housed within or on a mobile phone 35. The mobile phone 35 may also include a miniaturized VNA and/or data processor (not shown). That is, the mobile phone 35 may entirely include a miniaturized version of the system 1 that can essentially send generated blood glucose readings (as previously described with respect to FIG. 4 ) to an application associated with the smartphone 35.

7 , the first antenna 2 and the second antenna 5 are housed within or on a wearable wristband or watch strap 36 .

It is also contemplated that the first and second antennas 2, 5 could instead be housed within the body 40 of the watch itself, and preferably on the underside 41 of the watch body 40, whereby the first and second antennas 2, 5 are in direct contact with the person's skin 4 in the area of the wrist 8 (top or underside). It will be appreciated that if the person wears the system 1 (close to the skin 4), the system may be able to continuously detect the presence of, measure the concentration of, or otherwise monitor glucose 23 within the blood 14, which offers advantages over discontinuous finger-stick testing, which only measures blood each time the person manually pricks their finger and places the resulting blood on/in a glucose meter. Furthermore, being able to wear the watch 40 or band 36 continuously means that the person can continuously monitor their glucose levels while working, exercising, socializing, or sleeping.

The wearable wristband or watchband 36 may also contain a miniaturized VNA and/or data processor (not shown), whereby the band 36 may be considered to contain a miniaturized version of the system 1 as a whole. In such an embodiment, the band 36 or watch 40 may include a wireless transceiver (not shown) whereby the resulting blood glucose readings may be wirelessly transmitted to another electronic device as previously described.

With regard to Figure 8, four different possible configurations and numbers of first and second antennas 2, 5 that may be accommodated by or within a support means 34 (such as a PCB 22) are shown in Figures 8a, 8b, 8c and 8d.

In FIG. 8 a , there is a transmitting antenna 2 and a receiving antenna 5 arranged substantially parallel and side by side.

In FIG. 8 b , there is a transmitting antenna 2 and a receiving antenna 5 arranged substantially in parallel and end to end.

In FIG. 8 c , there is one transmit antenna 2 positioned substantially orthogonal to two substantially parallel receive antennas 5 positioned on either side of the first transmit antenna 2 .

In Figure 8d, there are three transmit antennas 2 positioned substantially orthogonal to the two substantially parallel receive antennas 5 positioned as shown.

System 1 has been tested and the results compared to those of a standard prick test. The following outlines the parameters of the test performed on a volunteer ("Volunteer 1"):

Methodology

1. On the day before the test day, Volunteer 1 had their "Personal Profile" tracked (using acetate film on a computer screen) and then practiced moving their arm to consistently obtain a trajectory that matched their "Personal Profile".

2. On the test day, monitor Volunteer 1 for a period of up to two (2) hours. They will be required to remain at the test facility during the period they are monitored.

3. On the morning of the test day, volunteers 1 were required to bring their blood glucose levels to between 5 and 7 mmol l ^-1 before commencing monitoring. This required volunteers 1 to abstain from eating until the test period.

4. During the monitoring period.

a. Before eating, Volunteer 1 is asked to perform two prick tests (within a few minutes of each other). The results of the prick tests are recorded (as a baseline).

b. Give the volunteers 1 moderate GI food (sandwich).

c. Immediately and then every five minutes, Volunteer 1:

• Place the sensor 1 (or PCB 22) on their arm so that the track is on their "personal profile" and measurements are taken and recorded.

●Perform a prick test.

d. The prick test results were monitored by a medical supervisor to ensure that Volunteer 1 never had low or high blood sugar levels.

e. Once the blood glucose level of volunteer 1 reaches 12-14 mmol.l ^-1 (or the prick test is stable), volunteer 1 is exempted from the test.

FIG9 shows a spectrum profile in the form of a graph showing the test results of volunteer 1.

Figure 10 is an Excel spreadsheet showing the conversion of spectral profile data into identifiable values for the blood glucose level of Volunteer 1 (compared to the equivalent prick test results). The formula used for the conversion is also provided.

As can be seen from Figure 10, the test results for Volunteer 1 using System 1 were mostly very close to the equivalent prick test results (remember that prick test results can vary by as much as 15% compared to more accurate laboratory testing methods).

variants

While the embodiments described above are presently preferred, it will be understood that a wide range of other modifications may be made within the general spirit and scope of the invention, and/or as defined by the appended claims.

Claims (22)

1. A non-invasive sensing system for measuring the concentration of a substance within an object, the system comprising: A support member configured to be placed near or against the surface of the object; A transmitting antenna, mounted on or within the support, configured to transmit electromagnetic radiation signals into the object; and A receiving antenna, mounted on or within the support and adjacent to the transmitting antenna, is configured to receive at least a portion of the electromagnetic radiation signal reflected back to the same surface of the object covered by the support, the transmitted electromagnetic radiation signal being reflected due to interaction with the material within the object being measured. Wherein, the central longitudinal axis of the transmitting antenna is orthogonal to the central longitudinal axis of the receiving antenna, the central longitudinal axis of the receiving antenna passes through the center of the transmitting antenna, or the central longitudinal axis of the transmitting antenna passes through the center of the receiving antenna, and the transmitting antenna and the receiving antenna are located in the same plane relative to each other. 2. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, the system further comprising an analyzer electrically communicating with the transmitting antenna and the receiving antenna, the analyzer being configured to decompose reflected signals received by the receiving antenna into a spectrum or spectral file. 3. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 2, the system further comprising a data processor configured to receive the spectrum or spectral file from the analyzer and to measure the concentration of the substance within the object. 4. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 2, wherein the support comprises: at least one first conductive track configured to electrically connect the analyzer to the transmitting antenna; and at least one second conductive track configured to electrically connect the analyzer to the receiving antenna, the at least one first conductive track being orthogonal to the at least one second conductive track. 5. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 2, wherein the analyzer is a vector network analyzer, i.e., a VNA, and the VNA uses S-parameters to decompose the received signal from the receiving antenna into a spectrum or spectral file. 6. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 2, the system further comprising an electronic control module, i.e., an ECM, configured to control the overall operation of one or more of the sensing system, the analyzer, and the data processor. 7. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the transmitting antenna and the receiving antenna are in direct contact with the surface of the object. 8. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 7, wherein the support is configured to be worn by a human. 9. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the non-invasive sensing system is configured to measure the concentration of the substance, which is a blood component in the blood of a living organism. 10. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the transmitted electromagnetic radiation signal is in one or more of the microwave spectrum and the radio spectrum. 11. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the transmitted electromagnetic radiation signal is transmitted continuously. 12. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the transmitted electromagnetic radiation signal is transmitted as a pulse or a linear frequency modulated pulse. 13. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the power of the transmitted electromagnetic radiation signal is less than 50 mW. 14. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the transmitting antenna is located between 0.05 mm and 10 mm from the receiving antenna. 15. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the transmitting antenna is configured to transmit the electromagnetic radiation signal into the object in a transmissive structure or mode, and the receiving antenna is configured to receive the reflected electromagnetic radiation signal in a transmissive structure or mode. 16. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the support comprises a printed circuit board, i.e., a PCB. 17. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the system is capable of or configured to operate automatically at a predetermined time. 18. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the system is capable of or can be configured to operate automatically and continuously. 19. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the system is capable of or configured to be manually operated by a user of the system. 20. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the system is capable of measuring the concentration of multiple substances at any given time. 21. The non-invasive sensing system for measuring the concentration of a substance within an object according to claim 1, wherein the support is in the form of a housing or a substrate, or comprises a housing or a substrate. 22. A non-invasive sensing system for measuring the concentration of a substance within an object, the system comprising: A support member configured to be placed near or against the surface of the object; At least one transmitting antenna, mounted on or within the support, the at least one transmitting antenna being configured to transmit electromagnetic radiation signals into the object; and At least one receiving antenna is mounted on or within the support and adjacent to the transmitting antenna. The receiving antenna is configured to receive at least a portion of the electromagnetic radiation signal reflected back to the same surface of the object covered by the support, the transmitted electromagnetic radiation signal being reflected due to interaction with the material within the object being measured. Wherein, the central longitudinal axis of the at least one transmitting antenna is orthogonal to the central longitudinal axis of the at least one receiving antenna, the central longitudinal axis of the at least one receiving antenna passes through the midpoint of the at least one transmitting antenna, or the central longitudinal axis of the at least one transmitting antenna passes through the midpoint of the at least one receiving antenna, and the at least one transmitting antenna and the at least one receiving antenna are located in the same plane relative to each other.